Generic Cozaar

[diana.papshev]

We received a question about the availability of generic Cozaar in connection with the confusion regarding patent delisting and the 6-month exclusivity for the first generic.

[diana.papshev]

Cozaar/Hyzaar:

First generic approval/launch forecast:

o Expected in 4/2010 (highly likely that >1 generic products will be approved and no 6-month exclusivity will be granted)

Background, details, and sources:

o All currently listed patents expire by 9/4/2014 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification (for the ‘075 patent) has been filed in 2004 but Merck decided not to pursue in courts; in fact Merck has asked the FDA to delist the ‘075 patent. Teva’s ANDA (1st application with paragraph IV) has paragraph III certifications for the ‘069 and ‘197 patents which expire by 4/6/2010 (the ‘079 patent relates to a method of treatment for which Teva does not seek approval); Teva receives 180-day exclusivity announced 3/2/2010 (Sources: Drugs@FDA; FDA’s list of Paragraph IV patent certifications); FDA Law Blog 6/09; FDA’s Orange Book; FDA Law Blog 3/10)
o Starting in 5/2006, the FDA issued tentative approvals for various manufacturers: Teva, Roxane, Lek, Zydus and Aurobindo. Although Teva was the first to file with paragraph IV certification for the ‘075 patent, it is technically no longer eligible for the 6-month exclusivity because Merck requested to delist this patent in 2006. In 8/2006 a DC court ruled that FDA’s forfeiture of the 6-month exclusivity would be appropriate in this case; Teva is appealing (Sources: Drugs@FDA; FDA Law Blog 8/09; FDA News 8/09)

Avapro

First generic approval/launch forecast:

o Expected in 3/2012

Background, details, and sources:

o All currently listed patents expire by 12/7/2015 (Sources: FDA’s Orange Book
o At least 1 ANDA with paragraph IV certification (for the ‘247 patent) has been filed in 5/2004 but it appears that BMS and Sanofi-Aventis decided not to pursue in courts. Ranbaxy’s ANDA has paragraph III certification for the other patent which expires by 3/30/2012 (Sources: FDA’s list of Paragraph IV patent certifications); BMS’ 2004 Annual Report; FDA’s Orange Book)
o Starting in 3/2007, the FDA issued tentative approvals for various manufacturers: Teva, Cipla and Sandoz. In terms of the 6-month exclusivity for the 1st generic, there could be a similar situation as with Cozaar/Hyzaar if BMS/Sanofi-Aventis also asked the FDA to delist the ‘247 patent (Sources: Drugs@FDA)

Avalide

First generic approval/launch forecast:

o Expected in 3/2012

Background, details, and sources:

o All currently listed patents expire by 12/7/2015 (Sources: FDA’s Orange Book
o At least 1 ANDA with paragraph IV certification (for the ‘348 patent) has been filed in 11/2004 but it appears that BMS and Sanofi-Aventis decided not to pursue in courts. Ranbaxy’s ANDA has paragraph III certification for the other patent which expires by 3/30/2012 (Sources: FDA’s list of Paragraph IV patent certifications); BMS’ 2004 Annual Report; FDA’s Orange Book)
o Starting in 5/2007, the FDA issued tentative approvals for various manufacturers: Teva, Mylan and Sandoz. In terms of the 6-month exclusivity for the 1st generic, there could be a similar situation as with Cozaar/Hyzaar if BMS/Sanofi-Aventis also asked the FDA to delist the ‘348 patent (Sources: Drugs@FDA)

Diovan/Diovan HCT

First generic approval/launch forecast:

o Expected in 9/2012

Background, details, and sources:

o All currently listed patents expire by 12/18/2017 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification has been filed starting in 12/2004 but Novartis decided did not pursue in courts except for the case with Ranbaxy’s ANDA with paragraph IV certification for the ‘578 patent. However, the companies agreed to drop the lawsuit and Ranbaxy amended it’s ANDA to paragraph III certification for the ‘578 patent which expires in 9/21/2012 (Sources: [ FDA’s list of Paragraph IV patent certifications); Novartis 2006 annual SEC filing; Patent Docs 11/07; Novartis 2008 annual SEC filing)
o FDA has issued tentative approvals for Ranbaxy and Ivax starting in 10/2007 (Mylan in 5/2008 for Diovan HCT). In terms of the 6-month exclusivity for the 1st generic, there could be a similar situation as with Cozaar/Hyzaar (Sources: Drugs@FDA)

Atacand

First generic approval/launch forecast:

o Expected in 12/2012

Background, details, and sources:

o All currently listed patents expire by 1/9/2014 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification (for the ‘075 patent) has been filed in 12/2006 but AstraZeneca decided not to pursue in courts. Sandoz’, Teva’s, and Mylan’s ANDAs have paragraph III certifications for the other patents which expire by 12/4/2012 (Sources: FDA’s list of Paragraph IV patent certifications); AZ’s 2008 Annual Report; AZ’s 2007 Annual Report; FDA’s Orange Book)
o In 4/2008, the FDA issued tentative approval for Lek’s generic. In terms of the 6-month exclusivity for the 1st generic, there could be a similar situation as with Cozaar/Hyzaar if AstraZeneca also asked the FDA to delist the ‘075 patent (Sources: Drugs@FDA)

Atacand HCT

First generic approval/launch forecast:

o Expected in 12/2012

Background, details, and sources:

o All currently listed patents expire by 2/24/2015 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification (for the ‘075 patent) has been filed in 6/2008 but AstraZeneca decided not to pursue in courts. Mylan’s ANDA has paragraph III certifications for most of the other patents which expire by 12/4/2012 (Sources: FDA’s list of Paragraph IV patent certifications); AZ’s 2008 Annual Report; FDA’s Orange Book)
o The FDA has not yet issued any tentative approvals. In terms of the 6-month exclusivity for the 1st generic, there could be a similar situation as with Cozaar/Hyzaar if AstraZeneca also asked the FDA to delist the ‘075 patent (Sources: Drugs@FDA)

Micardis/Micardis HCT
First generic approval/launch forecast:

o Expected in 1/2014 or later

Background, details, and sources:

o All currently listed patents expire by 1/10/2020 (Sources: FDA’s Orange Book
o At least 1 ANDA with paragraph IV certification has been filed starting in 12/2006. There is no record of litigation in the public domain and it appears that BI decided not to pursue in courts (Sources: FDA’s list of Paragraph IV patent certifications)
o In 5/2008, the FDA issued a tentative approval for Watson’s generic (just for Micardis) (Sources: Drugs@FDA)

Benicar/Benicar HCT

First generic approval/launch forecast:

o Expected in 4/2016

Background, details, and sources:

o All currently listed patents expire by 5/19/2022 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification has been filed starting in 4/2006. Daiichi Sankyo filed suits against Mylan and Matrix. In the Mylan case, the court affirmed the ‘599 patent which expires on 4/25/2016; Mylan is appealing (Sources: FDA’s list of Paragraph IV patent certifications); PatentDocs 10/2009; FDA’s Orange Book)
o FDA has issued tentative approvals for Mylan and Sandoz starting in 3/2008 (Mylan in 10/2008 for Benicar HCT) (Sources: Drugs@FDA)

Teveten/Teveten HCT

First generic approval/launch forecast:

o Expected in 8/2014 or earlier

Background, details, and sources:

o All currently listed patents expire by 8/12/2014 (Sources: FDA’s Orange Book
o No ANDA with paragraph IV have been filed at this time (Sources: FDA’s list of Paragraph IV patent certifications)
o FDA has not issued any tentative approvals (Sources: Drugs@FDA)

[chantell.reagan]

Of note, on 4/7/10 the FDA approved Teva's generic Cozaar and Hyzaar. Additionally, as the first to file an ANDA with paragraph IV certification, Teva recently won 180-day exclusivity for these generics, as a result of Merck delisting its patents.

Additional sources:
FDA news article 4/10
Teva product launches 2010
Teva press release 4/10
FDA law blog 3/10

[diana.papshev]

Anonymous member request:

"I am seeing conflicting information about the patents for the remaining ARBs. Are you able to provide any information about projected dates for Diovan, Atacand and Benicar?"

[chantell.reagan]

Please see the following updates:

Diovan/Diovan HCT

First generic approval/launch forecast:

o Expected in 9/2012

Background, details, and sources:

o All currently listed patents expire by 12/18/2017 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification has been filed starting in 12/2004 but Novartis decided did not pursue in courts except for the case with Ranbaxy’s ANDA with paragraph IV certification for the ‘578 patent. However, the companies agreed to drop the lawsuit and Ranbaxy amended it’s ANDA to paragraph III certification for the ‘578 patent which expires in 9/21/2012 (Sources: [ FDA’s list of Paragraph IV patent certifications); Novartis 2006 annual SEC filing; Patent Docs 11/07; Novartis 2008 annual SEC filing)
o FDA has issued tentative approvals for Ranbaxy and Ivax starting in 10/2007 (Mylan in 5/2008 for Diovan HCT). In terms of the 6-month exclusivity for the 1st generic, there could be a similar situation as with Cozaar/Hyzaar (Sources: Drugs@FDA)

Atacand

First generic approval/launch forecast:

o Expected in 12/2012

Background, details, and sources:

o All currently listed patents expire by 1/9/2014 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification (for the ‘075 patent) has been filed in 12/2006 but AstraZeneca decided not to pursue in courts. Sandoz’, Teva’s, and Mylan’s ANDAs have paragraph III certifications for the other patents which expire by 12/4/2012 (Sources: FDA’s list of Paragraph IV patent certifications); AZ’s 2008 Annual Report; AZ’s 2007 Annual Report; FDA’s Orange Book)
o In 4/2008, the FDA issued tentative approval for Lek’s generic. In terms of the 6-month exclusivity for the 1st generic, there could be a similar situation as with Cozaar/Hyzaar if AstraZeneca also asked the FDA to delist the ‘075 patent (Sources: Drugs@FDA)

Atacand HCT

First generic approval/launch forecast:

o Expected in 12/2012

Background, details, and sources:

o All currently listed patents expire by 2/24/2015 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification (for the ‘075 patent) has been filed in 6/2008 but AstraZeneca decided not to pursue in courts. Mylan’s ANDA has paragraph III certifications for most of the other patents which expire by 12/4/2012 (Sources: FDA’s list of Paragraph IV patent certifications); AZ’s 2008 Annual Report; FDA’s Orange Book)
o The FDA has not yet issued any tentative approvals. In terms of the 6-month exclusivity for the 1st generic, there could be a similar situation as with Cozaar/Hyzaar if AstraZeneca also asked the FDA to delist the ‘075 patent (Sources: Drugs@FDA)

Benicar/Benicar HCT

First generic approval/launch forecast:

o Expected in 10/2016

Background, details, and sources:

o All currently listed patents expire by 5/19/2022 (Sources: FDA’s Orange Book)
o Paragraph IV certification has been filed starting in 4/2006. Daiichi Sankyo filed suits against Mylan / Matrix. The court affirmed the ‘599 patent (in 9/10) which expires on 10/25/2016; Daiichi Sankyo appeals were denied (9/10 and 3/11). (Sources: FDA’s list of Paragraph IV patent certifications); PatentDocs 10/2009; FDA’s Orange Book; Diiachi Financials 5/11)
o FDA has issued tentative approvals for Mylan and Sandoz starting in 3/2008 (Mylan in 10/2008 for Benicar HCT) (Sources: Drugs@FDA)